Abstract

Aceclofenac is a phenylacetic acid derivative with potent analgesic and anti-inflammatory properties and an improved gastro-intestinal tolerance. In the present study, a reversed-phase HPLC method was developed for analysis of aceclofenac and applied for detection and quantification of aceclofenac specified impurity-B (methyl[2-[(2, 6-dichlorophenyl)amino]phenyl]acetate) with UV detection in bulk drug. Aceclofenac and its impurity were separated using an acetonitrile-phosphate buffer (60:40) isocratic method with a flow rate of 1 mL/min and UV detection at 275 nm. The retention times for aceclofenac and its impurity were 3.0 min and 13.04 min respectively. The method was validated as per ICH guidelines. The calibration was linear over the range of 1-25 mcg/mL for aceclofenac and 1-20 mcg/mL for Aceclofenac impurity-B. The method showed excellent sensitivity (detection limit of 10 μg/mL) with good precision and accuracy. This sensitive and selective method can be used for detection and quantification of aceclofenac impurity-B in aceclofenac bulk drug in order to control and regulate process related impurity.